OPERATION & MAINTENANCE MANUAL

Prevacuum Tabletop Autoclave

Model 2545 EVS

Cat. No. MAN205-0266006EN Rev. A Manufactured by: Tuttnauer Co. Ltd., Har Tuv Industrial zone B P.O.Box 170, Beit Shemesh 99000, IsraelTel: 972 2 9904611, Fax: 972 2 9904730

TABLE OF CONTENT 1 GENERAL .............................................................................................................. 4 1.1 1.2 1.3 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 3 3.1 3.2 3.3 4 5 4.1 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 INCOMING INSPECTION ................................................................................... 4 WARRANTY .................................................................................................... 4 WARRANTY STATEMENT ................................................................................ 4 INTRODUCTION ............................................................................................... 5 OPERATING CONDITIONS ................................................................................ 6 SPECIFICATIONS ............................................................................................. 7 UTILITIES ....................................................................................................... 8 ENVIRONMENT EMISSION INFORMATION ........................................................ 8 ELECTRICAL DATA ......................................................................................... 8 CONSTRUCTION .............................................................................................. 9 SYMBOL DESCRIPTION ................................................................................... 9 WATER QUALITY.......................................................................................... 10 DIRECTIVES AND STANDARDS ...................................................................... 11 PROGRAM 1 - (FLASH 134) ........................................................................... 14 PROGRAM 2 - (WDRY 134) ........................................................................... 15 PROGRAM 3 - (NODRY 121) ......................................................................... 16 PROGRAM 4 - (WDRY 121) ........................................................................... 17 PROGRAM 5 - (SLOW 121) ............................................................................ 18 PROGRAM 6 - (BD TEST) .............................................................................. 19 PROGRAM 7 - (VACTEST) ............................................................................. 20 DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD ............... 22 DESCRIPTION OF THE OPERATIONAL MESSAGES .......................................... 25 DISPLAYED ERROR MESSAGES AND SAFETY MEASURES .............................. 28 SETTING THE CLOCK ..................................................................................... 30 PRINTER OUTPUT ......................................................................................... 31 PRINTER HANDLING ..................................................................................... 33 PAPERNEAREND........................................................................................... 34 PAPEREND .................................................................................................... 34 MECHANICAL ALARM .................................................................................. 34 AUTO LOADING FUNCTION ........................................................................... 34 PLACING ....................................................................................................... 35 LIFTING AND CARRYING ............................................................................... 35 LOADING AND UNLOADING THE DEVICE ....................................................... 36 FILLING THE WATER RESERVOIR.................................................................. 36 PACKS .......................................................................................................... 38 TUBING......................................................................................................... 39 WRAPPED INSTRUMENTS .............................................................................. 39 Page 1 of 57

GENERAL INFORMATION ............................................................................... 5

KEYBOARD (KEYS AND DISPLAY) .............................................................. 21

CHECKING AND CHANGING PARAMETERS AND OTHER DATA ...... 30 PRINTER.............................................................................................................. 31

INSTALLATION ................................................................................................. 35

PREPARATION BEFORE STERILIZATION ................................................ 37

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OPERATING INSTRUCTIONS ........................................................................ 40 MAINTENANCE INSTRUCTIONS.................................................................. 42 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 PREVENTIVE AND SCHEDULED MAINTENANCE............................................. 42 DRAINING THE RESERVOIR ........................................................................... 44 REPLACING THE AIR FILTER ......................................................................... 46 REPLACING THE DOOR GASKET.................................................................... 47 REPLACING THE CARTRIDGE FUSE ............................................................... 48 CHECKING THE SAFETY VALVE .................................................................... 49 DOOR SAFETY SYSTEM................................................................................. 51 CLEANING WATER STRAINER ........................................................................ 52 CLEANING TABLE TOP AUTOCLAVES WITH CHAMBER BRITE................... 53

10 TROUBLESHOOTING ...................................................................................... 54 11 SPARE PARTS LIST .......................................................................................... 57 12 ACCESSORIES ................................................................................................... 57

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TABLE OF ILLUSTRATIONS FRONT VIEW ................................................................................................................. 12 REAR VIEW ................................................................................................................... 13 STERILIZATION PROGRAMS ........................................................................................... 14 FRONT PANEL KEYBOARD ............................................................................................ 21 TRAY HANDLE CMT240-0001 ..................................................................................... 56 POUCH RACK ACS215-0008........................................................................................ 56 TRAY TRY240-0001 ................................................................................................... 56 TRAY HOLDER TRH254-0001 ..................................................................................... 56

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GENERAL
Read the Operating Instructions carefully, before beginning any operation on the autoclave! 1.1 Incoming Inspection The autoclave should be unpacked and inspected for mechanical damage upon receipt. Observe packing method and retain packing materials until the unit has been inspected. Mechanical inspection involves checking for signs of physical damage such as: scratched panel surfaces, broken knobs, etc. If damage is apparent, contact your dealer or point of purchase, so that they may notify the manufacturer and file a claim with the appropriate carrier. All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination. Warranty We certify that this instrument is guaranteed to be free from defects in material and workmanship for one year against faulty components and assembly with the exception of glassware, lamps and heaters. The warranty does not include and does not replace routine treatment and preventive maintenance to be performed according to instructions in paragraph 9.1 (Preventive and Scheduled Maintenance). Our obligation is limited to replacing the instrument or parts, after our examination, if within one year after the date of shipment they prove to be defective. This warranty does not apply to any instrument that has been subjected to misuse, neglect, accident or improper installation or application, nor shall it extend to products that have been repaired or altered outside the factory without prior authorization from us. The Autoclave should not be used in a manner not described in this manual! Warranty Statement The warranty registration must be completed and returned to our service departments; within fourteen (14) days of purchase or the warranty will be void. Our Technical Service Depts can be reached at: A. Jaime Rojas, Jr. Garcia y Grarcia 870, Barranco, Lima, Peru Tel: 705 6500, Fax: 477 1316, e-mail: ventas@ajaimerojas.com If there is any difficulty with this instrument, and the solution is not covered in this manual, contact our representative or us first. Do not attempt to service this instrument yourself. Describe the difficulty as clearly as possible so we may be able to diagnose the problem and provide a prompt solution. If the autoclave is equipped with a printer, send along a copy of the last printout for our inspection. If replacement parts are needed, stipulate the model and serial number of the machine. No products will be accepted for repair without proper authorization from us. All transportation charges must be paid both ways by the owner. This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer. Page 4 of 57

1.2

1.3

Note:

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GENERAL INFORMATION
2.1 Introduction This table-top autoclave is designed for sterilization of surgical materials such as unwrapped and wrapped, solid, dental and medical clinics, first aid rooms, small laboratories etc. This autoclave model is an electrically heated sterilizer using steam as a sterilizing agent. The autoclave is designed as Type S in accordance with EN13060. This model is a prevacuum sterilizer having the following features; An air removal stage (prevacuum), before starting the sterilizing stage. A post-sterilization drying phase, based on the combined operation of heat and vacuum with air inlet pulses. 2.1.1 Displayed Pressure The autoclave is equipped with two pressure measuring devices: 1. A relative analogue manometer that is used for indication purposes only. The manometer displays the pressure in kPa and psi. 2. An absolute digital display that is used for monitoring and control purposes. This device displays the pressure in kPa or in psi, according to the operators requirement, and the absolute zero is displayed as 0. The analogue pressure gauge is used as a guide only. Should there be a power failure during the operation of the autoclave, the pressure gauge indicates to the operator that there is pressure in the chamber. The advantages of the prevacuum sterilizer are as follows: Removal of air pockets from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle. More efficient steam penetration into the load; assuring effective sterilization. Improved temperature uniformity. Better drying of materials due to the vacuum achieved in the chamber at the end of the sterilization cycle. A printer is an optional addition to the autoclave. The printer prints the preset and actual parameters of the cycle (temperature, time and pressure/vacuum). This manual is intended for the user and gives the user a general understanding of the instrument and the best ways to operate and take care of it in order to obtain effective results. After reading this manual, operating the autoclave will be easy. However since this instrument is built with high technology sensitive components, no attempt should be made by the user or any other unauthorized person to repair or recalibrate it. Only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to service the apparatus.

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2.2

Operating Conditions This device is for indoor use only! The sterilizer should be loaded only with autoclavable material! The environment shall not exceed an ambient temperature of 40C and a relative humidity of 85% respectively. As default, the operation altitude shall not be over 2000 meters (ambient pressure shall not be lower than 80 kPa (11.6 psi)). If the operation altitude is above 2000 meters, ExhTopTemp parameter must be changed by an authorized technician. The procedure for changing this parameter is described in the technician manual. It is recommended to perform a test cycle at the beginning of each working day. If the sterilized loads will include only porous or any material that does not include hand pieces perform a B & D test cycle.

CAUTION! Waste water should be brought into the public net in accordance with the local rules or requirements i.e. ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN PUBLIC SEWAGE!

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2.3

Specifications Property Chamber Chamber volume External dimensions Distance between supporting legs F - rear legs F1 - front legs Width (A) Height (B) Length (C) K F F1 Dia. Useable depth

Value 254 mm (10) 473 mm (18.6) 23 lit. (6.1 gal) 51 cm (20.1) 36.5 cm (14.4) 56 cm (20.0) 40 cm (15.75) 32 cm (12.6) 42.6 cm (16.8)

Overall Dimensions Front View Top View

Property Weight Weight per support area (max. load) Weight per support area (chamber filled with water) Shipping weight Width Height Shipping dimensions Length Volume Max. water volume Mineral-free water reservoir Min. water volume MAN205-0266006EN Rev A

Value 35 kg (77 lb) 1410 N/m2 (29.44 lb/ft2) 1955 N/m2 (40.81 lb/ft2) 60 kg (132 lb) 46 cm (18.1) 73 cm (28.7) 64 cm (25.2) 0.22 m3 (7.7 ft3) 2.9 lit. (0.77 US gal) 0.9 lit. (0.2 US gal) Page 7 of 57

Property Maximum dimensions (door D open) E Maximum load per item Maximum load per tray wrapped Maximum solid load unwrapped Maximum textile load Max. Allowable Working pressure (MAWP) W Tray dimensions H L No. of trays IMS cassettes 2.4 Utilities Utility Mineral free water Value

Value 90 cm (35.8) 65.5 cm (25.8) 0.2 kg (1.1 lb) 2.0 kg (4.4 lb) 1.5 kg (3.3 lb) 6.0 kg (13.2 lb) 1.0 kg (4.4 lb) 2.76 bar (40 psi) 17 cm (6.7) 2 cm (0.8) 41.5 cm (16.3) 4 3

Power supply 2.5

See table in para 2.9. On autoclaves with automatic mineral free water filling the Min. flow rate: 4lit/hr. 1ph, 10A/230V, 50 Hz

Environment Emission Information 1. The peak sound level generated by the autoclave is 65dBA with background noise of 48 dBa. 2. The total heat per hour transmitted by the autoclave is < 200 Wh.

2.6

Electrical Data Property Heaters Power Total Power Voltage (V) Amperage (A) Frequency (Hz) Protection against electrical shock Degree of protection by enclosure

Value 2200W 2300W 1 ph / 230 9.6 50/60 Class I (IEC 60601-1) IP31

Note: In order to avoid any injury by electrical hazard, it is recommended that a ground fault protection device be installed in the electrical panel feeding the autoclave (local codes may make this mandatory).

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2.7

Construction The main parts of the autoclave are made of materials as indicated below: Chamber is built of stainless steel 316 L. Door is made of stainless steel 304. Trays are made of stainless steel 304. Water reservoir is made of LLDPE. Door handle is made of hard plastic material, which is safe to touch and thermo-insulated.

2.8

Symbol Description Caution! Consult accompanying documents

Caution! Hot surface.

Caution! Hot steam.

Protective earth (Ground)

Stand by

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2.9

Water Quality 2.9.1 Physical characteristics and contaminants levels The distilled or mineral free water supplied to the autoclave should have the physical characteristics and maximum acceptable level of contaminants indicated in the table below: Physical Characteristics and Maximum acceptable contaminants levels in steam for sterlizers (According to EN 13060:2004). Condensate Element allowable content Silicium oxide. SiO2 0.1 mg/kg Iron Cadmium Lead Rest of metals except iron, cadmium, lead Chloride (Cl) Phosphate (P2O5) Conductivity (at 20C) pH value (degree of acidity) 0.1 mg/kg 0.005 mg/kg 0.05 mg/kg 0.1 mg/kg 0.1 mg/kg 0.1 mg/kg 3 s/cm

5 to 7 Colourless clean Appearance without sediment Hardness ( Ions of alkaline earth) 0.02 mmol/l Compliance with the above data should be tested in accordance with acknowledged analytical methods, by an authorized laboratory. Attention: We recommend testing the water quality once a month. The use of water for autoclaves that does not comply with the table above may have severe impact on the working life of the sterilizer and can invalidate the manufacturers guarantee. 2.9.2 Reverse Osmosis A Reverse Osmosis system may be used to improve the quality of the water used to generate steam in the autoclave chamber. The use of mineral free will contribute to better performance and longer life of the autoclave.

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2.10

Directives and Standards Every autoclave meets the provisions of the following Directives and is constructed in compliance with the following Standards: 2.10.1 Technical Directives 1. Medical Device Directive 93/42/EEC. 2. Pressure Equipment Directive 97/23/EEC. 2.10.2 Technical Standards 1. EN 13060:2004 Small Steam Sterilizers. 2. ASME Code, section VIII division 1 for pressure vessels. 3. EN 61010-1:01 Safety of electrical equipment General requirement. 4. EN 61010-2-040:2005 Particular requirement for steam autoclaves. 5. EN 50081-01 (EMC) Emission compatibility 6. EN 61000-1:97 (EMC) Immunity compatibility 2.10.3 Quality standards The manufacturing plant meets the following quality standards: 1. EN ISO 9001:2008 Quality System 2. ISO 13485:2003 Quality systems Medical devices. The manufacturer retains all supporting documentation.

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FRONT VIEW

14 13 12 10 9

3 4 5 6 7

No. 1 2 3 4 5 6 7 8 9 10 11 12 Autoclave cover Ventilation grid keyboard

Description Water reservoir cover

Printer opening cover Main switch RS232 port cover Door cover Model label water reservoir drain valve (behind door cover) Door closing device Door switch (behind door cover)

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REAR VIEW

10

No. 1 2 3 4 5 6 7 8 9 10

Description Vacuum pump fuse 1.25A Transformer fuse 0.5A Cut-off thermostat Circuit breaker Main power electric cable socket Water outlet strainer Air filter service cover Drain outlet Rear cover Ventilation grid

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STERILIZATION PROGRAMS The autoclave offers 5 sterilization programs, 2 test programs and one optional dry program. For changing any parameter refer to the Technician Manual. 2.11 Program 1 - (Flash 134) Program 1 is recommended for sterilizing unwrapped instruments. Load weight shall not exceed 6 kg. Nominal Parameters Sterilization temperature: 134C (273F). Temperature band: 0C +3C . Sterilization time: 4 minutes. Max. cycle time: 15 minutes. Average cycle time: 12 minutes. Operation Sequence Air-removal phase; One vacuum pulse as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature and pressure are maintained constant at the pre-set level for the sterilization time. Fast exhaust phase; steam is rapidly exhausted from the chamber, followed by a continuous vacuum pulse (0.5 minute) followed by vacuum break (air inlet), until pressure equalizes atmospheric pressure. The cycle was validated with a 6 kg unwrapped solid load. Note: The sterility of instruments processed in unwrapped cycles cannot be maintained if exposed to non-sterile environment.
PRESSURE (kPa) TEMPERATURE

140 kPa Ambient Pressure and Temperature

t1 = One pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage t4 = Continuous vacuum stage t5 = Air inlet stage

TIME 15 kPa

t1

t2

t3

t4

t5

Pressure

= Temperature

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2.12

Program 2 - (WDry 134) Program 2 is recommended for sterilizing porous, wrapped and Hollow B (e.g. dental hand pieces, suction pipes) loads at temperatures of 134C/273F with 15 minutes drying stage. Porous load weight shall not exceed 1.5 kg and wrapped load weight shall not exceed 1.5 kg. Nominal parameters Sterilization temperature: 134C (273F). Temperature band: 0C +3C. Sterilization time: 7 minutes. Dry time: 15 minutes. Max. cycle time: 45 minutes. Average cycle time: 35 minutes. Operation Sequence Air removal phase; One vacuum pulse as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature is maintained constant at the pre-set level for the sterilization time. Fast exhaust phase; steam is rapidly exhausted from the chamber, followed by a continuous vacuum pulse (5 minutes) followed by 10 minutes of interrupted vacuum pump operation, until pressure equalizes atmospheric pressure. The cycle was validated with a 1.5 kg wrapped solid and 1 kg textile load.
PRESSURE (kPa) TEMPERATURE

t1 = Four pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage t4 = Continuous vacuum stage t5 = Interrupted vacuum Stage

Ambient Pressure and Temperature

TIME

15 kPa

t1

t2 = Pressure = Temperature

t3

t4

t5

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2.13

Program 3 - (NoDry 121) Program 3 is recommended for sterilizing unwrapped delicate instruments at temperatures of 121C / 250F without drying stage. Load weight shall not exceed 6 kg. Unwrapped solid load shall not exceed 6 kg, porous load weight shall not exceed 1.5 kg and wrapped load weight shall not exceed 1.5 kg. Nominal parameters Sterilization temperature: 121C (250F). Temperature band: 0C +3C . Sterilization time: 20 minutes. Max. cycle time: 40 minutes. Average cycle time: 35 minutes. Operation Sequence Air removal phase; One vacuum pulse as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature is maintained constant at the pre-set level for the sterilization time. Fast exhaust phase; steam is rapidly exhausted from the chamber, followed by a continuous vacuum pulse (0.5 minute) followed by vacuum break (air inlet), until pressure equalizes atmospheric pressure. The cycle was validated with a 6 kg unwrapped solid load, 1.5 kg porous load and 1.5 kg wrapped load. Note: The sterility of instruments processed in unwrapped cycles cannot be maintained if exposed to non-sterile environment.
PRESSURE (kPa) TEMPERATURE

140 kPa Ambient Pressure and Temperature

t1 = One pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage t4 = Continuous vacuum stage t5 = Air inlet stage

TIME 15 kPa

t1

t2

t3

t4

t5

= Pressure = Temperature

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2.14

Program 4 - (WDry 121) Program 4 is recommended for sterilizing porous wrapped and Hollow B (e.g. dental hand pieces, suction pipes) loads as well as delicate instruments at temperatures of 121C/250F with 15 minutes drying stage. Porous load weight shall not exceed 1.5 kg and wrapped load weight shall not exceed 1.5 kg. Nominal parameters Sterilization temperature: 121C (250F). Temperature band: 0C +3C . Sterilization time: 20 minutes. Dry time: 20 minutes. Max. cycle time: 65 minutes. Average cycle time: 55 minutes. Operation Sequence Air removal phase; One vacuum pulses as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature is maintained constant at the pre-set level for the sterilization time. Fast exhaust phase; steam is rapidly exhausted from the chamber, followed by a continuous vacuum pulse (5 minutes) followed by 15 minutes of interrupted vacuum pump operation, until pressure equalizes atmospheric pressure. The cycle was validated with a 1.5 kg wrapped solid and 1 kg textile load.
PRESSURE (kPa) TEMPERATURE

t1 = Four pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage t4 = Continuous vacuum stage t5 = Interrupted vacuum Stage

Ambient Pressure and Temperature

TIME

15 kPa

t1

t2 = Pressure = Temperature

t3

t4

t5

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2.15

Program 5 - (Slow 121) Program 5 is recommended for sterilizing delicate and unwrapped instruments that need a slow exhaust at temperatures of 121C/250F without drying stage. Nominal parameters Sterilization temperature: 121C (250F). Temperature band: 0C +3C. Sterilization time: 20 minutes. Max. cycle time: 45 minutes. Average cycle time: 37 minutes. Operation Sequence Air removal phase; two vacuum pulses as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature is maintained constant at the pre-set level for the sterilization time. Slow exhaust phase; steam is slowly exhausted from the chamber, until pressure equalizes atmospheric pressure. The cycle was validated with a load of 30 Silicon tubes with a length of 25cm each.

Note: The sterility of instruments processed in unwrapped cycles cannot be maintained if exposed to non-sterile environment.
PRESSURE (kPa) TEMPERATURE

t1 = Two pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage

140 kPa Ambient Pressure and Temperature

TIME

15 kPa

t1

t2 = Pressure = Temperature

t3

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2.16

Program 6 - (BD Test) Program 6 is the Bowie & Dick test program, with fixed sterilization parameters 134C and 3.5mins, which cannot be modified by the operator or the technician. Nominal parameters Sterilization temperature: 134C Sterilization time: 3.5 minutes. Dry time: 1 minutes. Operations Sequence Air removal phase; One vacuum pulse as described in the diagram below. Mineral free water is introduced into the chamber. Saturated steam is produced in the chamber until the sterilization temperature is reached. Sterilization phase; temperature is maintained constant at the pre-set level 134C for sterilization time 3.5 minutes. Fast exhaust phase; steam is rapidly exhausted from chamber until pressure equalizes atmospheric pressure. Drying phase; vacuum in chamber for 1 minute while chamber is heated at reduced power. The cycle was validated with a B&D load.

PRESSURE (kPa) TEMPERATURE

t1 = Four pulse air removal stage t2 = Sterilization stage t3 = Exhaust stage t4 = Continuous vacuum stage t5 = Air inlet Stage

140 kPa Ambient Pressure and Temperature 15 kPa TIME

t1 = Pressure = Temperature

t2

t3

t4

t5

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2.17

Program 7 - (VacTest) Note: Before performing this test, verify that the autoclave is cold and that the autoclave is dry (not humid and no water drops). Vacuum is produced in the chamber down to P1=17 kPa. At this stage all the valves close. The autoclave remains in this stage for 5 minutes. This period enables the condition in the chamber to reach equilibrium. After the 5 minutes have elapsed the printer records the pressure that is referred to as P2. At this point the test begins and lasts 10 minutes. At the end of the test, the printer records the results. The pressure at the end of the test is referred to as P3. The rate of change of P3-P2 shall not exceed 0.13 kPa/min. If P3-P2 exceed 1.3 kPa the printer will print TEST FAIL. If P3-P2 is within the required value, the cycle will end normally. Operations Sequence Vacuum is produced into the chamber down to 17 kPa. The vacuum pump stops.

Note: During the test period the autoclave is not heated.

PRESSURE (kPa)

t1 = Approx. 4 minutes t2 = 5 minutes t3 = 10 minutes total = Approx. 20 minutes

Ambient Pressure TIME P3 P2 P1=17 kPa t1 t2 t3

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KEYBOARD (keys and display)

Front Panel Keyboard

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3.1

Description and Functions of the Front Panel Keyboard The command panel is divided in 3 sections. On the lower section there are 6 keys; 3 command keys and 3 programming keys. The middle section consists of the LCD display with two rows and 16 characters on each line. The top section consists of 4 signal lights that indicate the status of the autoclave. 1. Start/ Stop key This key commands the following 3 functions: Starting the process. Stopping the process. Canceling the FAIL message from the command panel and opening the electric door locking. Starting the process: It is active while the autoclave is in READY position, if the door is closed and water level in the reservoir is normal. Pressing this key starts the selected process. Stopping the process: It is active while the autoclave is in process. Pressing this key at any stage of the process stops operation. Canceling the FAIL message At the end of an aborted process, the FAIL light is turned on and an error message is displayed on the screen indicating the cause of the failure. Pressing this key cancels the displayed message and switches off the FAIL light. 2. Parameters key This key displays for 5 seconds the three parameters of the program. After selecting the program, it is possible to have the parameters displayed by pressing this key; the top line reads the following data: Sterilization time

S = 15min
Dry time

D = 15 min.

The data is erased automatically after 5 seconds, or if the parameter key is pressed again during these three seconds.

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3.

Sel. Cycle (select cycle) key This key enables selecting the desired program out of 8 programs. Pressing this key advances the selected program to the next (e.g. from program 2 to 3). If the system is set to program 7, pressing the key returns to program 1. This autoclave has the following available programs: 1. Unwrapped instruments without drying. 134C (273F)/ 4 minutes. 2. Porous and wrapped. 134C (273F)/ 7 minutes with 15 minutes drying. 3. Unwrapped delicate instruments without drying. 121C (250F)/20 minutes. 4. Porous and wrapped. 121C (250F)/20 minutes with 20 minutes drying. 5. Delicate and unwrapped instruments that need a slow exhaust, at 121C (250F)/20 minutes without drying. 6. Bowie & Dick Test. 7. Vacuum Test.

4.

Display The display is used to display the current status of the autoclave while using Operational Messages and Error Messages.

5.

Start led indicator When the START LED indicator is on; it indicates that the system is running a program.

6.

Fail led indicator When the FAIL LED indicator is on; it indicates that the cycle has failed either as a result of exceeding the allowable limits or the STOP key has been pressed.

7.

Water led indicator When the WATER LED indicator is on; it indicates that there is a lack of water in the mineral free water reservoir.

8.

Door led indicator If the Start key is pressed and the door is unlocked the light will remain on and the buzzer will sound six times. If a cycle is in progress and fails on door unlocked FAIL LED indicator will be lit and a message Door Open will be displayed.

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9.

Program key This key is designed for entering changes in the programs. The operator can perform the following: 1. 2. Change the date. Change the time.

Note: Access to other programming level is possible only through a special code and may be performed only by authorized personnel. 10. UP key This key enables increasing the value displayed above the cursor, at the clock programming and for setting of certain parameters by the technician. 11. DN key This key enables decreasing the value displayed above the cursor, at the clock programming and for setting of certain parameters by the technician.

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3.2

Description of the Operational Messages The display is divided in 2 rows, each row has 16 characters. 4.2.1 The upper row: On the right side of the upper row, 6 characters are allotted for displaying the stage in progress ST. BY VACUM HEAT STER EXH DRY P1V P(n)H TEST WAIT 1 WAIT 2 READY Open Door Wait Autoclave in stand by mode. Vacuum stage. Heating stage. Sterilization stage. Exhaust stage Dry stage Air-removal stage - vacuum pulse. Air-removal stage - heat pulse. Vacuum stage (t1) during Vac test. Stabilization stage (t2) during Vac test Test stage (t3) during Vac test Autoclave is ready to begin a cycle. Order to open door at end of cycle Waiting period between cycles.

On the left side of the upper row, 10 characters are allotted for the selected programs. Europe Flash 134 Wdry 134 NoDry 121 Wdry 121 Slow 121 BD Test VacTest USA Flash 273 Wdry 273 NoDry 250 Wdry 250 Slow 250 BD Test VacTest

Program 1 Program 2 Program 3 Program 4 Program 5 Program 6 Program 7

When the PARAMETERS key is pressed; the parameters of the selected program are displayed.

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4.2.2

The lower row: On the right side of the lower row, 5 characters are allotted for chamber pressure display. The actual pressure is continuously displayed at all stages of the process and between processes (standby). On the left side of the lower row the temperature is displayed; 5 characters are allotted for the display of temperature in C or F, in the form 134.3 or 273.4. In case the process is aborted, the diagnosis of the fail is displayed on the left side of the lower row, instead of the temperature. 11 characters are allotted for this error message. On completion of the process, the CYCLE END message is displayed on the left side of the lower row. For BD Test and VacTest the message on completion of the cycle will be TEST ENDED. At the sterilization and dry stage, the countdown of the time left to the completion of the stage will be displayed between the readouts of temperature and pressure. The format of the display will be MM: SS (two digits for minutes and two digits for seconds). During the period between cycles, while wait is displayed on the upper row, the count down timer is displayed on the middle of the lower row. This period lasts 10 minute. When this time passes, wait disappears and a new cycle may be started. When a cycle is started by means of pressing the START key, the load number is displayed for 2 seconds on the left of the lower row. It is impossible to perform a cycle immediately after completing a cycle. To perform the next cycle, open the autoclave's door and wait 10 minutes until the chamber cools down.

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Examples Example 1:

Autoclave between processes, the program No.1 has been selected, the door is still open and START has not been pressed yet.

Selected program 134 Flash

Status

Flash 134 135

ST.BY 100K

Temperature in chamber

Pressure in chamber

Example 2:

The autoclave is in the sterilization stage, program No.3 is active and the time left to completion of sterilization phase 3 minutes and 14 seconds. Stage

Selected program 134W.dry

Wdry 135

134 03:14

STER 318K

Temperature

Timer

Example 3:

The process failed due to temperature drop in the sterilization stage in program No.6.

Slow

121

Fail 178K

LOW TEMP.

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3.3

Displayed Error Messages and Safety Measures Low Temp. Message is displayed, FAIL indicator lights and cycle is aborted, if the temperature drops for more than 5 seconds below the sterilization temperature. Low Heat Message is displayed and sterilization does not start if the autoclave has not reached sterilization temperature after heating for 20 minutes. Message is displayed, FAIL indicator lights and the cycle is aborted in one of the following cases: If temperature rises 3C (6F) above sterilization temperature during the sterilization stage. If temperature sensor is damaged, this message appears during the HEAT stage. Message is displayed, FAIL indicator lights, and the cycle is aborted if the pressure drops for more than 5 seconds below the pressure correlated to the sterilization temperature. This message is displayed, FAIL indicator lights, and the cycle is aborted if pressure rises above the pressure correlated to the sterilization temperature +3C (6F) for more than 5 seconds.

High Temp.

Low Pres.

High Pres.

Low Vacuum Message is displayed and FAIL indicator lights if, in the vacuum stage, the required vacuum level is not reached during 20 minutes after the cycle is started. Man. Stop Power Dn Message is displayed and the FAIL indicator lights after the STOP key is pressed for longer than 1 second. Message is displayed if a power failure occurred during sterilization stage. When power resumes, the system automatically returns to the point of power failure. This message is displayed for several seconds and the printer prints POWER DN. If the temperature does not fall below the sterilization temperature, sterilization resumes automatically. When power returns, and temperature falls below sterilization temperature, the cycle will stop, exhaust will be performed according to the program requirements and POWER DN & FAIL messages will be displayed and printed. If a power failure occurs during the HEAT stage, heating resumes (provided there is enough water in the chamber). If not, the cycle aborts. Dry and exhaust stages automatically resume operation once the power is back on. Message is displayed and the WATER LED indicator is lit in case of insufficient water in the water reservoir. After water is added to the reservoir, the START/STOP indicator button must be pressed, to start the required sterilization cycle.

Fill Water

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Door Open

Message is displayed and the DOOR LED indicator is lit if the door is improperly closed. The START button should be pressed to start the desired cycle. If the door accidentally opens during any stage of the cycle, the same message and indicator appears, and the system reacts as if the START/STOP key was pressed. Message is displayed when there is a leakage during vacuum test or when there is a failure during B&D test. Message is displayed if the autoclave has not been used for 4 hours and no push-button has been pressed during this period. The Sleep message will be displayed without backlight and the START LED will blink during the Sleep period. To exit the Sleep status, press any push-button.

Test Fail Sleep

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CHECKING AND CHANGING PARAMETERS AND OTHER DATA

In order to set the autoclave's clock, check the main sterilization parameters (sterilization temperature sterilization time, and dry time) and to print the sterilization of one of the 10 previous cycles, you can enter three subdirectories and obtain the required data. Setting the clock can be done by the operator, the other functions are only accessible for authorized persons through an access code. 4.1 Setting the clock This directory enables you to set the time and date. 1. 2. 3. 4. Press PROGRAM pushbutton. ENTER CODE will be displayed. If, at this point, CYCLES is pressed, Set Clock will be displayed. To enter the Clock settings press CYCLES again.

When entering the set clock display the time and date are displayed. The curser is blinking on the digits for the hour. The time is displayed in the upper row in the form hh:mm:ss. The hour range is 24 hour (i.e. from 0 to 24) The date is displayed in the lower row in the form DD:MM:YY. 1. To increase or decrease the time or the date use the UP and DOWN pushbuttons. 2. 3. To move the curser from one digit to another press the PARAMETERS pushbutton After completing setting the time and the date press SEL. CYCLE to confirm the new time and date and to exit press PROGRAM twice.

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PRINTER
The printer is an optional device. If the autoclave is not equipped with a printer paragraph 6 is not applicable. 5.1 Printer Output The autoclave is equipped with a character printer, which prints a detailed history of each cycle performed by the instrument (for the record or for subsequent consideration). The printing is made on plain paper with 24 characters per line and contains the following information: Software version Date and Time Selected program Sterilization pressure Sterilization temperature Sterilization time Summary of performed cycle and identification hints. When the sterilization cycle begins the printer starts printing the above data. After the preliminary printing, the autoclave starts performing the sequence of operations of the cycle. The measured values of temperature and pressure are printed at fixed time intervals, according to the phase of the process, as shown in the table below. The data is printed from the bottom up, beginning with the date and ending with O.K. for a complete cycle or FAIL for an aborted cycle. For an example of a typical printout, see next page.

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PRINTER OUTPUT

DESCRIPTION

Operator: Time: 19:19:03 Date: 13/02/2005 CYCLE ENDED D 00:49:34 061.5 038.9 * * * D 00:29:34 117.5 102.9 ----------------------E 00:29:24 120.4 116.8 E 00:28:24 134.7 310.8 ----------------------S 00:28:24 134.7 310.8 * * * S 00:21:24 134.1 310.7 ---------------------H 00:20:50 129.7 275.6 * H 00:08:50 082.6 070.2 ---------------------V 00:03:19 019.3 022.4 * * * V 00:00:00 020.8 093.5 Time C kPa Dry Time: Ster Time: Ster Temp: 020.0min 007.0min 134.0C

To be filled in manually by operator Time sterilization cycle ended Date sterilization cycle ended. The time, temperature and pressure during drying. Prints drying data every 3 minutes. The time, temperature and pressure during drying. The time, temperature and pressure during exhaust. The time, temperature and pressure during exhaust. The time, temperature and pressure during sterilization. Prints sterilization data every 1 minute. The time, temperature and pressure during sterilization. The time, temperature and pressure during heating. Prints sterilization data every 3 minute The time, temperature and pressure during heating. The time, temperature and pressure during air removal. Prints sterilization data every 3 minute or on upper and lower peak (the shorter time) The time, temperature and pressure during air removal. Drying time for selected program. Sterilization time for selected program. Sterilization temperature in chamber for selected program Description of cycle (with dry). Cycle counter Version of parameters setting Program's name and version. Autoclave's serial number. Time sterilization cycle started. Date sterilization cycle started.

Cycle: WDry Load number: 0067 Param. Ver: 0040 Ver: Scls 1.16 Ser.Num: 02407163 Time: 18:29:29 Date: 13/02/2005 Legend V H S Vacuum stage Heating stage Sterilization stage

E D

Exhaust stage drying stage

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5.2

Printer Handling

The printer is an optional device. If the autoclave is not equipped with a printer paragraph 5 is not applicable. The printer is driven and controlled automatically by the control unit, while the autoclave performs a sterilization program.

Figure 1

Figure 2

To set the paper roll in the printer perform the following steps: 6.2.1 Gently push the clips for removing the front panel, remove the panel and pull out the printer gently. 6.2.2 Set the paper roll on the shaft (See Figure 1). Since the outer and inner surfaces of the paper are different set the roll so that the printing surface is the outer. Gently push the paper face down into insertion opening (A) in Figure 2. Keep pressing the feed switch (B) until the paper comes out from the print head (C). When the paper emerges from the print head, insert it in the paper cutter (the slot in the front panel) and reassemble the front panel on the unit.

6.2.3

6.2.4

The paper roll is set inside the unit and the printer is ready for use.. NOTE: If the paper is not pulled in by the rollers even when you press the feed switch (B) push the paper in. 6.2.5 To ensure a reliable operation of the printer perform the following: 6.2.5.1 6.2.5.2 Turn the main switch to the OFF position. Turn the main switch to the ON position; press the feed switch at the same time. Verify that the printer performs an operation test by printing all the built-in characters

The following precautions have to be taken ensuring the proper operation of the printer: Avoid contact between the paper and the hot parts of the autoclave, as the paper will be blackened. Do not pull out the paper roll from the paper insertion opening. Use only the 58mm. wide thermal paper rolls, supplied by your dealer. Page 33 of 57

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5.3

PaperNearEnd When the paper roll is near the end, the paper-near-end is detected and printing is stopped. Power supply to the printing solenoid and motor is immediately stopped and BUSY PE signals are active. When data still exists in the input buffer, the remaining data in the buffer is printed before stopping. Discharge remaining paper with the LF switch, set new paper and push the LF switch. Then normal print mode is created after cancellation of BUSY and PE output. This function can be selected by Dip-Switch setting. PaperEnd This feature detects that there is no paper in the printer. When there is no printing paper, printing stops and BUSY and PE signal are active. The paper led will be lit. Printing is also stopped in case data remains in the input buffer. Install a new paper roll as described in para. 5.5 Then BUSY PE is cancelled. When auto loading function is available, printer automatically feeds recording paper a few lines by inserting the recording paper into the paper inlet. Mechanical Alarm When trouble in the mechanism results in locking of the motor, power supply to the printing solenoid and motor is stopped and BUSY signal as well as FAULT signal are active. To recover from alarm state, after correcting causes for the malfunction, either re-supply power or input RESET signals. For severe trouble, turn power off and call for service. Auto Loading Function This printer is equipped with a function that can automatically load paper. With paper inserted, it is automatically fed a few lines. When printing paper is not perpendicular to the printing head or not properly fed, take out paper gently and insert it once again. If not using this function, cancel this with the Dip-Switch. Paper insertion is, then, performed with the LF switch. After paper is inserted, with the LF switch pressed and detached, print ready state is created.

5.4

5.5

5.6

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INSTALLATION
6.1 Placing CAUTION: The sterilizer must be placed on a rigid and leveled surface. The stand must be able to withstand the load of the device and loaded material. 1. Counter top able to support a minimum of 70 kg. 2. Counter space minimum 51cmW x 60cmD (20.1W x 20D) * (see unit dimensions) Placing the Autoclave The autoclave has an inclination of approx. 2 towards the rear. This ensures that water is completely drained out of the chamber through the opening at the bottom rear of the chamber. NOTE: Keep the back and the sides of the autoclave approximately 2 (50 mm) away from the wall to allow ventilation. If placed in a cabinet, verify that the rear of the cabinet is open to allow ventilation. Insufficient space for ventilation may result in an increase of the autoclave's temperature that may damage the instrument. It is recommended that enough space be left around the autoclave to give a technician access for servicing the machine. 7.1.2 6.2 Connections to Utility Supplies Plug the power cord into the supply socket.

7.1.1

Lifting and carrying

CAUTION: Before moving the autoclave, Make sure that the electric cord is disconnected from the power, and there is no pressure in the chamber. 1. 2. Disconnect the power supply cord. Drain the water from both reservoirs.

To avoid injuries, lifting and carrying should be done with at least two persons or by using a fork-lift or any other mechanical aid. Do not drop this device!

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6.3

Loading and unloading the Device 7.3.1 Safety Protective equipment and clothes and other safety instructions should be implemented in accordance with local and national regulations and/or rules! For proper sterilization - Do not overload the chamber. Only autoclavable products shall be used; please refer to the manufacturer instructions for sterilization of unknown materials or instruments. Loading Correct loading of the autoclave is essential for successful sterilization for several reasons. Efficient air removal from the chamber and the load will permit total steam penetration and saturation. Additionally, correct loading will reduce damage to packs and their contents and maximize efficient use of the sterilizer. For detailed loading instructions, see para. 8 (Preparation before sterilization) Unloading On completion of the cycle, the load shall be visual inspected to ascertain that the load is dry, and that sterilization indicators have made the required colour change.

7.3.2

7.3.3

6.4

Filling the Water Reservoir Remove the water reservoir cover. Pour distilled water into the reservoir through the opening on top of the autoclave until it reaches the base of the safety valve holder, approximately 0.7 gallons (3 liters). Use water-having characteristics as per table in para 2.11 Caution: Under no circumstance should water be filled above the safety valve holder. Use mineral free water only. Tap water may clog the system.
EXIT FOR STEAM

SAFETY VALVE HOLDER SAFETY VALVE

(ON HIDEN SIDE)

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PREPARATION BEFORE STERILIZATION

The purpose of packaging and wrapping of items for sterilization is to provide an effective barrier against sources of potential contamination in order to maintain sterility and to permit aseptic removal of the contents of the pack. Packaging and wrapping materials should permit the removal of air from the pack, penetration of the sterilizing water vapor into the pack and removal of the sterilizing vapor. The basic principle determining the size, mass and contents of instrument and hollowware packs is that the contents are sterile and dry immediately on completion of the drying cycle and removal of the pack from the sterilizer chamber. Instruments to be sterilized must be clean, free from any residual matter, such as debris, blood, pads or any other material. Such substances may cause damage to the contents being sterilized and to the sterilizer. 1. 2. 3. 4. Immediately after use, clean instruments thoroughly to dispose any residue. It is recommended to wash instruments with an ultrasonic cleaner, using detergent and mineral-free water. Launder textile wraps prior to reuse. After cleaning, rinse instruments for 30 seconds. (Follow manufacturers instructions on the use of products for cleaning and lubricating instruments after using the ultrasonic cleaner). Materials, including materials used for inner wraps, shall be compatible with the item being packed and the sterilizing method selected. Before placing an instrument into the sterilizer tray, make sure that instruments which are not of the same metal, (stainless steel, carbon steel, etc.) are separated and placed on different trays. Note: Check manufacturers instructions for the sterilization of each item.

5. 6.

7.

In case carbon steel instruments are placed on stainless steel trays, the trays should be lined with a towel or paper wrap before placing the instruments on the trays. There should be no direct contact between the carbon steel and the stainless steel trays. All instruments must be sterilized in an open position. Use single-use wraps only once and discard them after use. Place a sterilization indicator strip in each tray. Place instruments with ratchets opened and unlocked or clipped on the first ratchet position.

8. 9. 10. 11.

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12.

Disassemble or sufficiently loosen multiple-part instruments prior to packaging to permit the sterilizing agent to come into contact with all parts of the instrument. Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that only minimal resistance to removal of air, the passage of steam and condensate will be met. Load items within the boundaries of the tray so that they do not touch the chamber walls, or fall off when the tray is in move. The operator may use racks to allow adequate separation of packaged instruments. Load trays loosely to capacity. Once a week, use a biological spore test indicator in any load to make sure sterilization is performed. Make sure that all instruments remain apart during the sterilization cycle. Empty canisters should be placed upside-down, in order to prevent accumulation of water. Allow a distance of approximately 2.5 cm (1) between trays to permit steam circulation. Packs 1. Place packs upright on trays, side by side. 2. Packs should not touch the chamber walls. 3. Pack instrument sets in a manner that prevents damage to delicate items. 4. Pack hollowware sets so that all openings face the same direction and so that the contents cannot move inside the pack. 5. Load packs of folded operating room drapes with layers vertical, allowing air to be removed from the packs rapidly. 6. Do not place packs of hollowware and trays of instruments above textile packs or soft goods in order to avoid wetting caused by condensation from items above. 7. Load items packed in flexible packaging materials on edge with paper to laminate, or flat with the paper surface downwards.

13.

14. 15. 16. 17. 18. 19. 20.

7.1

Note: The manufacturers recommendations shall be observed, concerning the sterilization data for each type of material. ATTENTION Use only single wrap packs. MAN205-0266006EN Rev A Page 38 of 57

7.2

Tubing When placing in a tray, Make sure that both ends are open, without sharp bends or twists. Wrong

Right

7.3

Wrapped Instruments 1. Wrapped instruments should be packed in material that promotes drying such as autoclave bag, autoclave paper, and muslin towels. 2. It is highly recommended to utilize the Tuttnauer Pouch Rack. This rack allows the operator to place pouches on their side, thus increasing the capacity of the autoclave significantly and promoting better drying of the instruments. Contact your dealer for details. 3. Verify that the packaging method is in accordance with good

practice approach and the packaging materials are in accordance with the applicable standards (e.g. EN868 series). We recommend to use plastic-plastic or plastic-paper pouches. ATTENTION Use only single wrap.

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OPERATING INSTRUCTIONS
To avoid possible damage, do not leave the autoclave un-attended while in operation 1. Remove the water reservoir cover. Pour distilled water into the reservoir through the opening on top of the autoclave until it reaches the level of the upper floatswitch, approximately 6.5 liters (1.72 gallons). Insert the plug into the socket and switch on the circuit breaker on the backside of the machine. Turn on the main switch mounted on the front panel to power the control circuits. Set the clock for the proper date and time, by means of the PROGRAM key (9), UP (10) and DOWN (11); see section 4.1 and 5.1. Press the CYCLES key (3) to select the required program. The name of the program is displayed indicating the program has been selected. Press PARAMETERS key (2) to monitor the nominal parameters of the program. Load the material to be sterilized into the chamber, and close the door. Due to inherent elasticity of the door gasket, the DOOR LED indicator may indicate that the door is closed before a complete seal is made between the door and the chamber. Therefore, in order to ensure the door is fully sealed, continue to tighten the door bolt until hand-tight. Do not over - tighten the bolt as this may result in damage to the gasket. Should the autoclave fail to reach the sterilizing temperature / pressure, always check if the door is fully sealed. If not, tighten the door bolt further, as described above, until completely sealed. 8. Press the START/ STOP key to put the autoclave into operation. The autoclave starts performing sequence of operations. The actual measured values of pressure and temperature are displayed continuously and printed every minute at STE stage, and every 2 minutes at the other stages. The phase in progress is displayed at the right side of the upper line as VACUM, HEAT, STER., EXH., and DRY. During the air removal stage the following is displayed at the middle of the bottom line: the pulse number followed by a letter indicating the operation in progress V-vacuum, H-heating, E-exhaust (Ex. P1V). If the operator presses the START key and the door is not completely closed, the process will not start and the DOOR light will remain on, DOOR OPEN will be displayed and the buzzer will sound six times.

2. 3. 4. 5. 6. 7. Note:

CAUTION: Do not touch the strainers cover, mounted on the exhaust line, shortly after operation. Touching the hot strainers cover may cause severe injuries. MAN205-0266006EN Rev A Page 40 of 57

9.

At the end of the cycle, the START light is put off, the END message is displayed and the buzzer will ring a continuous sound for 7 seconds. In case of a failed cycle, the diagnosis of the failure followed by the FAIL!!! message will be displayed and printed and the buzzer will output an interrupted sound. Open the door and unload the sterilized material from chamber. In case of fail press the START/STOP key to cancel the locking of the door. For unloading hints see para. 7.3.3 (Unloading).

10.

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MAINTENANCE INSTRUCTIONS
9.1 Preventive and Scheduled Maintenance The maintenance operations described in this chapter have to be fulfilled periodically to keep the device in good condition and to reduce the breakdown time to a minimum. The user can easily execute these operations in accordance with further instructions. The owner of the autoclave is responsible to order an authorized technician to perform the periodical tests and preventive maintenance operations, as specified in para. 10.1.3.2. Use only mineral-free water as detailed in para. 2.9 (water quality). 10.1.1 Daily Clean door gasket with a soft cloth. The gasket should be clean and smooth. 10.1.2 Weekly Take out the tray holder and trays. Clean the tray holder, trays and chamber's interior (especially its bottom part) with a cleaning agent & water. Wipe off the sediments from the chamber bottom with a sponge. You may use diluted Chamber Brite solution as cleaning agent. To prepare this solution, pour one bag of Chamber Brite into 3/4 1 liter of warm mineralfree water. Immediately after cleaning, rinse the tray holder, trays and chamber's interior with water to avoid stains on the metal. 2. Clean and descale the chamber, copper tubes and reservoir using Chamber Brite (see para. 10.9). CAUTION: Do not use steel wool or steel brush as this can damage the chamber! 3. 4. 5. Put a few drops of oil on the 2 door pins and door tightening bolts. Clean the outer parts of the autoclave with a soft cloth. Replacing mineral free water If the autoclave was not used, drain the water from the mineral free water reservoir once a week, and refill with fresh mineral-free water or distilled water (see para. 10.2). By the operator 1. 2. Once a month activate the safety valve (see para. 10.6). Once a month clean the strainer as per para. 10.8. Cleaning frequency may be reduced according to experience. 1.

10.1.3

Periodically 10.1.3.1

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3.

Replace the air filter, every 3 months or after 500 cycles (the shorter period) according to para. 10.3. Once every six months clean the fan grid with a vacuum cleaner from the outer side of the grid. Check the door gasket every 12 months and replace it if required (see para. 10.4).

4. 5.

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10.1.3.2

By a qualified technician 6 months Tightening the screws of the heaters and the electrical connections at the heaters, valves and connectors in the control box. Year Checking the continuity of the grounding connections. Calibrating the temperature and pressure. Performing validation of the autoclave. Checking the precise operation of the earth leakage relay. Checking that the autoclave is leveled. Checking the safety elements; safety valve, cutoff thermostat, door locking mechanisms. Checking the operation sterilization parameters etc. sequences, the

Checking the water reservoir, piping, plastic parts and electric wires. Checking and tightening the piping joints to avoid leakage. Checking and tightening all screw connections in the control box, heaters and valves and instrumentation. 5 years Checking the closing device for excessive wear. Performing safety tests (pressure vessel, efficiency, electrical) according to local rules or regulations. Only an authorized inspector may perform this. 9.2 Draining the Reservoir Caution Before starting, ensure that the electric cord is disconnected and there is no pressure in the autoclave. The drain valve is located on the front left side of the autoclave after the door is opened. The function of the drain valve is to drain the water reservoir. 1. Connect the silicone hose, supplied with the autoclave, to drain into a bucket. 2. Turn drain valve counter clockwise to the open position. 3. Fully drain the reservoir. 4. With a quart of tap water flush out the reservoir MAN205-0266006EN Rev A Page 44 of 57

5. Turn drain valve clockwise to the close position. 6. Connect the electric cord to power source. 7. Fill the reservoir with distilled water to just below the safety valve (see sec 7.4) 8. Turn on the main power switch. 9. The autoclave is now ready for use.

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9.3

Replacing the Air Filter In order to break the vacuum, at the end of the dry phase, filtered atmospheric air enters the chamber via a solenoid valve. The filtration of the air is performed by the bacteriological filter that is placed at the inlet of the chamber. The bacteriological filter is mounted at the inlet of the chamber, through a solenoid valve. The filter is mounted near an opening on the rear wall of the autoclave enclosure, to ease access for replacing it. To replace the filter proceed as follows: 1. Remove the filter cover (2), by turning the cover counterclockwise until it is released. 2. 3. 4. 5. 6. Remove the filter (3) from the filter cover by unscrewing the filter from the filter cover. Cut the tie wrap (4) fixing the flexible tubing (5) connecting the filter to the copper pipe, and pull off the filter. Replace the filter with a new one. Connect the filter (3) to the flexible tubing (5) and tightening it with a tie wrap (4). Connect the filter to the filter cover by screwing the filter (3) into the hole in the cover (1). Insert the filter to its place inside the autoclave and reassemble the filter cover by turning it a turn clockwise. Verify that the cover is fastened well in its place.

2 Page 46 of 57

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9.4

Replacing the Door Gasket

Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points 1, 2 and 3. CAUTION! This gasket is designed with a trapezoidal cross section. The gasket should be placed with the widest side towards the door.

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9.5

Replacing the Cartridge Fuse

CAUTION! Make sure that the electrical power cord is disconnected! Use a screwdriver to unlock the fuse holder cover by turning it counter clockwise a little, and pull it out. Insert a new cartridge into the holder and turn the cover clockwise until locked. Make sure that the right fuse is installed as marked below!

No. 1 2

Cat. No. ELE035-0074 ELE035-0055

Description Transformer fuse 0.5A

Vacuum pump fuse 1.25A

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9.6

Checking the Safety Valve In order to prevent the safety valve from blockage, it is necessary to allow the steam pressure to escape through it (every month). To avoid injuries begin this check while the autoclave is cold.

9.6.1

PED-approved type safety valve 1. Operate the sterilization cycle according to the manual. 2. 3. 4. Allow a pressure of approx. 200 kPa (29-psi) to build up in the chamber. Remove the water reservoir cover. Turn the pressure relief nut clockwise for 2 seconds. Verify steam escapes from the valve.

Attention: Use protective gloves in order not to burn your hands with the hot steam. 5. 6. Press the STOP key to interrupt the operation, and exhaust steam from the chamber. Wait until the pressure decreases to zero, only then can the door be opened.

No. 1 2 3

Description Safety valve base Safety valve Pressure relief nut

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9.6.2

ASME-approved type safety valve 1. 2. 3. 4. Operate the sterilization cycle according to the manual. Allow a pressure of approximately 200 kPa (29-psi) to build up in the chamber. Remove water reservoir cover Operate the safety valve. Pull the ring of the safety valve using a tool, i.e. screwdriver, hook etc and lift the safety valve ring for 2 seconds. Be careful not to burn your hands. Press the STOP key to pause operation, and exhaust steam from chamber. Wait until pressure goes down to zero, only then can the door be opened.

5. 6.

Attention: Use protective gloves in order not to burn your hands with the hot steam. 5. 6. Press the STOP key to interrupt the operation, and exhaust steam from the chamber. Wait until the pressure decreases to zero, only then the door can be opened.

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9.7

Door Safety System The door opening is ensured by two means: a. The closing device prevents an incidental opening of the door. b. A pull-type solenoid that in inactivated position locks the door and must be electrically powered to release the locking and enable the opening of the door. 9.7.1 Solenoid locking device The solenoid locks the door in the following situations: 1. When the control unit is not powered. 2. If power failed or has been turned off while the autoclave is in operation, even if power has been restored. 3. If operation was stopped before completion of the cycle as a result of a failure or a manual stop. For cases described at points 2 and 3, press START/STOP key to cancel the door locking at the end of the operation. If, for any reason, the locking mechanism does not open, do not use force to open the door. Turn the closing device a quarter (1/4) turn clockwise (closing direction) and re-try to open the door. Do not use force to open the door. If, despite operating according to the instructions above, the door does not open, call an authorized technician.

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9.8

Cleaning water strainer

CAUTION! Before proceeding, Make sure that the electric cord is disconnected and there is no pressure in the autoclave. 1. Open the strainer cover. 2. Remove the strainer element. 3. Rinse the strainer with water. Use a brush if necessary. 4. Reinstall the strainer element. 5. Close the strainer cover. CAUTION! Do not touch the strainers cover, mounted on the exhaust line, shortly after operation. Touching the hot strainers cover may cause severe injuries. If maintenance operation is performed while strainer cover is hot, use heat resistant gloves to avoid injuries.

3 No. 1 2 3 4 5 6

Description Water strainer Silicon cover Cap Gasket Strainer element Strainer housing

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9.9

Cleaning Table Top Autoclaves with Chamber Brite CHAMBER BRITE is a cleaning and descaling agent designed specifically for the cleaning and removal of water deposits, oxides and other sediments that are found in steam sterilizers. The material is a combination of acidic salts and additional cleaning materials. Cleaning Procedure 1. Important all steps in this procedure must be completed without interruption. 2. When the autoclave chamber is cold, remove instruments and trays from the autoclave. 3. Open the door and spread the contents of a packet in a straight even line along the bottom of the chamber, from back to front. 4 Select and start program No. 1. When the cycle is finished exhaust the unit. 5. At the end of the exhaust cycle drain the water from the reservoir. 6. Fill the water reservoir with distilled water. 7. Repeat a sterilization cycle without Chamber Brite powder, to remove any excessive dirt in the pipes. Select and start program No. 1. When the cycle is finished exhaust the unit 8. At the end of the exhaust cycle drain the water from the reservoir. 9. Turn the autoclave off and allow chamber to cool. 10. Remove the tray holder; wipe the interior of the chamber with a damp cloth. 11. Fill the reservoir with distilled water or mineral free water only. 12. The instrument is ready to use. IMPORTANT: DO NOT sterilize instruments during the cleaning process!!! CAUTION: Keep out of reach of children. Contains mildly acidic ingredients. Avoid contact with the skin, eyes or clothing. Wash hands well after touching the powder, in the case of eye contact flush with continuous running water for at least 15 minutes. If irritation persists get medical attention. If accidentally swallowed, do not induce vomiting, drink large amounts of water and obtain medical attention. MSDS available upon request. Use one packet of CHAMBER BRITE. Clean every 20 cycles or as needed.

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10

TROUBLESHOOTING

Only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to service the apparatus. Solution 1.1 1.2 1.3 1.4 1.5 2.1 2.2 Verify that the main switch is in the On position. (see front view drawing). Make sure the power cord is properly connected to the machine and the power source. (see rear view drawing) Check the reset button on the cut-out thermostat. (see rear view drawing) Make sure the circuit breaker has not tripped. Lift circuit breaker's lever if necessary. (see rear view drawing) Verify that there is electrical power in the main source. Check the door for leakage and replace the door gasket, if necessary. (see para. 10.4, Replacing the Door Gasket) Make sure the pump is running. Check the pump fuse and replace it if necessary. (see para. 10.5, Replacing the Cartridge Fuse).

Problem

MAN205-0266006EN Rev A 4.1 Verify that the mineral free water supply is O.K.

10.1 display is not activated

10.2 Low Vacuum is displayed

10.3 Low Heat is displayed 3.1 Make sure the machine has the proper amount of sterilization load.

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10.4 ' Add water' is displayed

Problem 5.1 5.2 Make sure the paper is mounted in the right way. Only one side of the paper is printable. (see para. 5.2, Printer handling)

Solution

If equipped with a printer 6.1 6.2 6.3 7.1 Make sure the feed button on the printer is not stuck.

MAN205-0266006EN Rev A Make sure the paper is inserted in the printer. (see para. 5.2, Printer handling) 9.2 Switch off the machine and switch it back on while pressing the feed button on the printer. If the printer prints a test printout, the printer is O.K. and there is a problem with the electronics. Contact your dealer to solve the problem. If the printer does not print the test printout, there is a problem with the printer. Contact your dealer to solve the problem. 8.1 Make sure the door is tightened enough. Replace the door gasket. (see para. 10.4 Replacing the Door Gasket)

10.5 The printer prints, but nothing is printed on the paper.

10.6 The printer does not print.

10.7 When the machine is switched on, the printer gives paper feeds all the time. on, the printer feeds paper all the time.

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10.8 The machine is leaking at the door

If the problem persists, contact your dealer or point of purchase for further assistance.

TRAY HANDLE CMT240-0001

POUCH RACK ACS215-0008

TRAY TRY240-0001

TRAY HOLDER TRH254-0001

MAN205-0266006EN Rev A

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SPARE PARTS LIST

PART NUMBER ELE035-0055 ELE035-0074 FIL175-0046 FIL175-0042 GAS080-0184 THE002-0003 DESCRIPTION Fuse, Slow Blow, 1.25A, 6.3x32mm Fuse, Slow Blow, 0.5A, 5x20mm Screen, 400 Micron, For Strainer 1/4" Filter, Air, 0.2 Micron, Model 50mm D Gasket, Door, Black, 2540 Paper, Roll, Printer, DPU-20

12

ACCESSORIES
PART NUMBER ACS215-0008 CMT240-0001 GAS084-0007 THE002-0005 TRH254-0001 TRY240-0001 WIR040-0002 DESCRIPTION Pouch rack Handle, Tray Drain P.V.C. Tube, 8x12 Printer, DPU-20, Seiko Holder, Tray Tray, perforated, St.St Cable, Electric, Plug + Socket 230V 16A, EUR

MAN205-0266006EN Rev A

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